Sr. Manager, Regulatory Affairs
Sr. Manager, Regulatory Affairs
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Gilead Regulatory Affairs is a committed and proud team of highly skilled professionals dedicated to helping deliver therapies in the most efficient and effective way to patients with unmet medical need around the world. We bring our passion for science, discovery, and innovative strategic thinking into everything we do. Our advanced regulatory expertise, track record for developing systems and processes, and our commitment to science allow us to play a strategic role as leaders at Gilead and with global regulatory bodies as we seek to develop new therapies for unmet needs.
We are an inclusive and diverse community, which is supported by strong leaders who are committed to providing individual development and growth opportunities while achieving our mission. Our collaborative and supportive structure help support work-life balance for our teams.
The Sr. Manager will serve as the US and/or global regulatory lead and will provide strategic regulatory guidance on early/mid stage clinical development for biologic(s) and/or small molecule(s). She/he will represent regulatory affairs at cross-functional team meetings and will serve as the primary contact with the FDA for the assigned project(s).
Regulatory Affairs Sr. Manager Job Details:
- Responsible for developing regulatory strategy for assigned projects, and proactively identifying risks/issues and develop mitigation and/or contingency plan
- Responsible for leading the preparation, compilation and the timely filing of regulatory submissions which require interaction with departments outside of Regulatory Affairs for investigational products. Examples include pre-IND meeting request, briefing package, original IND, IND amendment and routine submissions (annual reports, DSUR, IB update, etc.)
- Lead cross functional teams in the authoring of regulatory documents including pre-IND meeting requests, IND clinical and nonclinical sections
- Critically review documents for submission to regulatory authorities
- Represents regional Regulatory Affairs or may serve as Regional Lead on cross-functional/cross-regional Regulatory Submission Teams
- Participates on other Sub-teams (e.g. Study Management, Clinical, Nonclinical, Biomarkers)
- Maintains knowledge of regulatory requirements up to current date, comments on draft regulatory guidance, and communicates changes in regulatory information
- Initiates or contributes to local and/or global process improvements which have a significant impact on the Regulatory Affairs function or other departments
- Work is performed under limited direction and supervision from a Senior Regulatory Affairs professional
Education, Professional Experience, and Skills:
- 8+ years of experience in Regulatory Affairs or other relevant industry experience with BS/BA
- 6+ years of experience in Regulatory Affairs or other relevant industry experience with advanced degree
- Degree in a scientific field is preferred
- Experience as Regional Regulatory Lead managing investigational products and representing Regulatory Affairs on cross-functional teams is required
- Biologics and combination products experience is a plus
- Must have demonstrated strategic and critical thinking with ability to execute
- Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements and understand the current global and regional trends in Regulatory Affairs and ability to assess the impact of these requirements to the business
- Must be capable of developing and implementing regulatory strategies and leading small teams in execution of strategy
- Must be capable of reviewing technical documents and influencing colleagues across functions
- Must be capable of effectively leading teams in preparation of submissions
- Excellent organizational skills and ability to work on and/or oversee several projects under tight timelines
- Excellent verbal and written communication skills and interpersonal skills require
- Work is performed under limited direction of a senior Regulatory Affairs professional
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
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